Infacort®: a new formulation of immediate release hydrocortisone.

• Research type

  Research Study

• Full title

  A single centre, open label, randomised, crossover study in dexamethasone-suppressed healthy adult male volunteers to compare the pharmacokinetics of Infacort® versus immediate-release hydrocortisone tablets at a single dose of 10mg and to evaluate the dose proportionality of Infacort® at doses of 0.5mg, 2mg, 5mg and 10mg.

• IRAS ID

  126044

• Sponsor organisation

  Diurnal Ltd

• Eudract number

  2013-000260-28

• Research summary

  The purpose of this study is to test a newly-developed formulation of immediate release hydrocortisone called Infacort. The study will assess how this drug acts once inside the body, by measuring cortisol levels in the blood following different strength doses. This will also help us figure out the extent to which Infacort becomes available to the body, compared to the already marketed hydrocortisone tablet.\n\nThe population who are eligible to take part in the study are healthy male volunteers, aged between 18 and 60 years of age.\n\nThe study consists of a screening visit, 5 treatment periods, where subjects will receive the study medication and a post study visit to discharge subjects from the study.

• REC name

  Wales REC 1

• REC reference

  13/WA/0094

• Date of REC Opinion

  13 May 2013

• REC opinion

  Further Information Favourable Opinion